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Project: Safety Protection and Cleanroom Rooms Renovation at Solid Dosage Facility
Project Budget
85MM
Project Description
Oversee the renovation of cleaning rooms to allow the manufacture products with solvents. Some of the renovation include, but is not limited to, adding fire retardant rooms walls, upgrade of the fire protection monitoring system, dust collection system, and equipment safety technology.
Impact
Increase manufacturing capabilities and eliminate compliance risk.
Customer
Sandoz
Project: Packaging Operations Upgrades at Multi-dosage facility
Project Budget
25MM
Project Description
Lead the replacement of packaging equipment obsolete technology with new one for thermoforming, bottling/packing, inspection system, case packer for LYO, Parenteral and solid dosage products.
Impact
Increase Manufacturing efficiency, reduce technology obsolescence and eliminate compliance risk
Customer
Merck
Project: Startup of a New Medical Device Facility
Project Budget
80MM
Project Description
Lead startup upon turnover to commercial operations. Design the facility new layout including associated requirements and applicable approvals. Manage the evaluation and selection of construction contractors. Oversee the construction activities upon completion. Obtain equipment and critical systems components base on URSs developed.
Impact
Increase manufacturing capabilities, ensure adequacy of technology obsolescence and alignment with local/federal regulatory requirements
Customer
Ocular Science
Project: Inspection System Upgrades at Finished Product Facility
Project Budget
47MM
Project Description
Replace obsolete inspection technology with a new vision system, add product serialization and aggregation confirmation for Parenteral finished product (i.e. vials, syringes, LYO, ampules).
Impact
Efficiency improvement and elimination of compliance risk
Customer
Hospira
Project: Design a New Aseptic Processing Fill and Finish Facility
Project Budget
100MM
Project Description
Oversee the design of a new state of the art facility, define requirements for clean rooms to perform aseptic processing, and obtain CAPEX approvals. Lead the evaluation, selection, and performance monitoring of construction contractors. Obtain equipment needed and critical systems components based on approved URSs developed.
Impact
Increase manufacturing capabilities and improve compliance
Customer
Hospira
Project: Renovate Cell Tissue Manufacturing Facility
Project Budget
5MM
Project Description
Manage renovation design and construction activities for sterile rooms at Human Cell Tissue Facility. Determine cleaning rooms facility requirements. Be in charge of the engineering contractor’s selection.
Impact
Remediation plan commitment implementation for compliance liability
Customer
Duke – School of Medicine
Project: Process redesign at Biologic Production Site
Project Budget
5.2MM
Project Description
Lead manufacturing line startup of vial aseptic filling process upon turnover to commercial operations. Manage technology design team for equipment upgrades implementation. Supervise, and recommend internal and external resources allocation. Oversee testing of the hardware and software technologies for compliance with IT guidelines and URSs.
Impact
Increase operational efficiency by 95% thru the reduction in nonconformities and replacement of technology obsolescence
Customer
Amgen
Project: Energy Saving Program at Biological Production Site
Project Budget
4MM
Project Description
Drive new technology design for HVAC systems. Oversee the equipment selection. Assign technical resources for project execution. Manage technology implementation and testing requirements base on Engineering URSs. Confirm sustainability of the technology implemented based on the energy saving program goals.
Impact
Reduce energy consumption by reducing 50% in energy utilization (Electricity, Steam, Chilled water) and overall energy cost decrease.
Customer
Amgen
Project: Design a New Packaging Line at an Opioids Production Site
Project Budget
2.2MM
Project Description
Design a manufacturing room to house a new packaging line for Opioids and establish all engineering requirements. Responsible for assessing project budget for estimate alignment. Select and order the equipment technology needed.
Impact
Increase manufacturing packaging capacity, efficiency, and reduce packaging process downtime caused by changeovers.
Customer
Purdue
Project: Renovate Aseptic Processing Production Site
Project Budget
45MM
Project Description
Direct the planning, design, construction, fabrication, installation, and qualification during aseptic core renovation. Manage internal and external engineers during the equipment refurbish and facility restoration. Lead facility startup timely turnover to commercial operations.
Impact
Increase manufacturing capabilities, efficiency, and elimination of compliance risk.
Customer
Luitpold